Home Applications 091076 Application 091076
Type ANDA
Sponsor NOVEL LABS INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 DIAZEPAM DIAZEPAM GEL;RECTAL 10MG/2ML (5MG/ML) No No 002 DIAZEPAM DIAZEPAM GEL;RECTAL 20MG/4ML (5MG/ML) No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A091076-001 DIAZEPAM DIAZEPAM 10MG/2ML (5MG/ML) GEL / RECTAL AB 2023-05-30 A091076-002 DIAZEPAM DIAZEPAM 20MG/4ML (5MG/ML) GEL / RECTAL AB 2023-05-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 2 · 44 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A091076-001 DIAZEPAM 10MG/2ML (5MG/ML) GEL / RECTAL AB 2023-05-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091076-002 DIAZEPAM 20MG/4ML (5MG/ML) GEL / RECTAL AB 2023-05-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091076-001 DIAZEPAM 10MG/2ML (5MG/ML) GEL / RECTAL AB 2023-05-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091076-002 DIAZEPAM 20MG/4ML (5MG/ML) GEL / RECTAL AB 2023-05-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091076-001 DIAZEPAM 10MG/2ML (5MG/ML) GEL / RECTAL AB 2023-05-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091076-002 DIAZEPAM 20MG/4ML (5MG/ML) GEL / RECTAL AB 2023-05-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091076-001 DIAZEPAM 10MG/2ML (5MG/ML) GEL / RECTAL AB 2023-05-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091076-002 DIAZEPAM 20MG/4ML (5MG/ML) GEL / RECTAL AB 2023-05-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091076-001 DIAZEPAM 10MG/2ML (5MG/ML) GEL / RECTAL AB 2023-05-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091076-002 DIAZEPAM 20MG/4ML (5MG/ML) GEL / RECTAL AB 2023-05-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091076-001 DIAZEPAM 10MG/2ML (5MG/ML) GEL / RECTAL AB 2023-05-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091076-002 DIAZEPAM 20MG/4ML (5MG/ML) GEL / RECTAL AB 2023-05-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091076-001 DIAZEPAM 10MG/2ML (5MG/ML) GEL / RECTAL AB 2023-05-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091076-002 DIAZEPAM 20MG/4ML (5MG/ML) GEL / RECTAL AB 2023-05-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091076-001 DIAZEPAM 10MG/2ML (5MG/ML) GEL / RECTAL AB 2023-05-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091076-002 DIAZEPAM 20MG/4ML (5MG/ML) GEL / RECTAL AB 2023-05-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091076-001 DIAZEPAM 10MG/2ML (5MG/ML) GEL / RECTAL AB 2023-05-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091076-002 DIAZEPAM 20MG/4ML (5MG/ML) GEL / RECTAL AB 2023-05-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091076-001 DIAZEPAM 10MG/2ML (5MG/ML) GEL / RECTAL AB 2023-05-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A091076-002 DIAZEPAM 20MG/4ML (5MG/ML) GEL / RECTAL AB 2023-05-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091076-001 DIAZEPAM 10MG/2ML (5MG/ML) GEL / RECTAL AB 2023-05-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091076-002 DIAZEPAM 20MG/4ML (5MG/ML) GEL / RECTAL AB 2023-05-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091076-001 DIAZEPAM 10MG/2ML (5MG/ML) GEL / RECTAL AB 2023-05-30 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091076-002 DIAZEPAM 20MG/4ML (5MG/ML) GEL / RECTAL AB 2023-05-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091076-001 DIAZEPAM 10MG/2ML (5MG/ML) GEL / RECTAL AB 2023-05-30 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091076-002 DIAZEPAM 20MG/4ML (5MG/ML) GEL / RECTAL AB 2023-05-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091076-001 DIAZEPAM 10MG/2ML (5MG/ML) GEL / RECTAL AB 2023-05-30 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A091076-002 DIAZEPAM 20MG/4ML (5MG/ML) GEL / RECTAL AB 2023-05-30 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A091076-001 DIAZEPAM 10MG/2ML (5MG/ML) GEL / RECTAL AB 2023-05-30 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A091076-002 DIAZEPAM 20MG/4ML (5MG/ML) GEL / RECTAL AB 2023-05-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A091076-001 DIAZEPAM 10MG/2ML (5MG/ML) GEL / RECTAL AB 2023-05-30 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A091076-002 DIAZEPAM 20MG/4ML (5MG/ML) GEL / RECTAL AB 2023-05-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A091076-001 DIAZEPAM 10MG/2ML (5MG/ML) GEL / RECTAL AB 2023-05-30 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A091076-002 DIAZEPAM 20MG/4ML (5MG/ML) GEL / RECTAL AB 2023-05-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A091076-001 DIAZEPAM 10MG/2ML (5MG/ML) GEL / RECTAL AB 2023-05-30 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A091076-002 DIAZEPAM 20MG/4ML (5MG/ML) GEL / RECTAL AB 2023-05-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A091076-001 DIAZEPAM 10MG/2ML (5MG/ML) GEL / RECTAL AB 2023-05-30 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A091076-002 DIAZEPAM 20MG/4ML (5MG/ML) GEL / RECTAL AB 2023-05-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A091076-001 DIAZEPAM 10MG/2ML (5MG/ML) GEL / RECTAL AB 2023-05-30 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A091076-002 DIAZEPAM 20MG/4ML (5MG/ML) GEL / RECTAL AB 2023-05-30 a67488948f0b…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 44 observed states.
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Diazepam DIAZEPAM Lupin Pharmaceuticals,Inc. d99b68aa-b3dc-49c8-8894-3da255cd26b0 2025-12-10 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 091076 application number: ANDA091076
Documents# Document, Submission type, Date table Document Submission type Date 74534 ORIG 2023-06-16